Pallavi Dhillon, PharmD, Ph.D., I am at ClinFomatrix, NJ, USA and New Delhi, India, CEO, Head of Clinical Operations and Drug safety, USA, more than 5 years and managing drug safety program globally, Quality Review of ICSRs, write and review safety narratives, pharmacovigilance Control document, monitoring of the compliance of outsourced pharmacovigilance activities. Lead concepts of quality management and inspection readiness within the study Clinical project monitoring and management to ensure that clinical trial project and process work was conducted to internal and external standards. This included ensuring that all colleagues, both internal as well as preferred CROs and partners, were regulatory inspection ready and staff were compliant with ICH GCP and relevant national and international regulations and guidelines and corporate policies and SOPs. Conducting clinical site feasibility studies as well as clinical site identification starting from Phase-I to Phase-IV. Monitoring the clinical sites as per monitoring plan to ensure that Principal Investigator(s) are conducting the study as per Protocol, ICH-GCP & SOPs. I have experience in neuroscience drug development and safety: schizophrenia, depression, mania, bipolar disorder, pediatric bipolar, pediatric schizophrenia, neuropathic pain, inflammation; osteoarthritis in CNS patients. I also have significant experience in Oncology: Phase 1-3 clinical trials, Solid tumor studies; lung cancers, head and neck, breast, liver, colorectal, prostate, ovarian; hematologic tumors, leukemia, myeloma blood disorders. I also led the Cardiovascular: Lipid studies, Women's health: Osteoporosis; migraine, non-interventional studies, Infectious disease: HIV/AIDs; vaccine; upper respiratory tract infections, pediatric sinusitis, Specialty Care/Other Therapy Areas: Inflammation, rheumatology, urology. I completed my doctor of philosophy, master and Bachelor in pharmacy, MDU Rohtak, India. I worked at leading pharmaceutical companies; Baxter Healthcare India, Pharmacovigilance Specialist, India, Pfizer Pharmacovigilance Officer, New Delhi, India, and was responsible for all AEs, SAEs, medication errors, product complaints. Differentiating between Initial and Follow up reports using ARGUS Working on database Pfoenix and ARGUS for comparison of Adverse Events and completing follow-up reports. QC of cases, AEM report forms for any kind of errors. Undergo client mentorship as designated by the project manager. I also worked as Clinical Research Associate, Sir Ganga Ram Hospital, New Delhi, and managed phase 3 protocols, recruitment, patient screening, patient consent forms and follow up management with Investigator. Maintained source documentation and drug accountability, SAEs reporting, maintaining site master file. HIPPA inclusions for IRB/IEC submission. I was Trainee Clinical Research Associate, Clinsys CRO, Noida, India and Assisted in conduction of BA/BE studies. To prepare readiness of the clinical facility and all study/system related documents for the audit process (QA audit, any regulatory Sponsor audit etc) at all / times. I completed internship at Clinsys Clinical Research Organization, Clinical Research Coordinator, Retention/recruitment Patient in India. I am member of Pharmacy Associations of India and a registered pharmacist in India.